The present invention relates to transferring liquids between containers and, more particularly, to a method and apparatus for automatically hydrating powdered medicaments in vials and transferring the hydrated medicaments within the vials to a container.
Referring now to FIG. 1, in a conventional pharmacy compounding setting, medicaments are often supplied in a dry, powder form within a vial, generally designated 10. Such vials 10 are well understood by those of ordinary skill in the art. Each vial 10 includes a bottom 12 having a periphery 14 and a wall 16 extending generally upwardly from the periphery 14. The container bottom 12 and container wall 16 define an interior container portion 18 which receives the powdered medicament 20. The container wall 16 extends upwardly to form a shoulder 22 and a neck portion 24. The neck portion 24 has an opening which receives a vial septum 26 for sealing the opening and providing access to the interior container portion 18 by piercing the vial septum 26 with a medical needle 28 or spike, such as a hollow transfer or hypodermic needle, in a manner well understood by those of ordinary skill in the art. Many vials 10 include a metallic cap 27 which surrounds and maintains the vial septum 26 in the opening defined by the neck portion 24.
It is the technician's responsibility to reconstitute or hydrate the powdered medicament 20 in the vial 10 and transfer the reconstituted medicament to a sterile IV bag or bottle(not shown in FIG. 1) from which the reconstituted medicament can be dispensed, such as with a syringe. The technician places as many as one to one hundred vials 10 containing the powdered medicament 20 into a laminar flow hood (not shown). A peristaltic pump 30 with first and second sets of transfer tubing 32, 34 and a container 36 of sterile liquid 38, such as water, are also placed under the laminar flow hood. The pump 30 is used to transfer the sterile liquid 38 from the container 36 into the vials 10 for the purpose of reconstituting the powdered medicament 20. The technician connects the first transfer tubing set 32 between the pump 30 and the container of sterile liquid 36. For instance, where the container 36 of sterile liquid 38 is an IV bag, the spike end 32a of the first transfer tubing set 32 is connected to the IV bag. The second transfer tubing set 34 extends between the pump 30 and a Luer lock connector 40 to which is attached the transfer needle 28.
To reconstitute the dry, powdered medicament 20 within the vial 10, the technician pierces the vial septum 26 of the vial 10 with the transfer needle 28 and then manually actuates the pump 30 to begin transferring the sterile liquid 38 from the sterile liquid container 36 to the vial 10, as represented by the arrows 38 in the first and second sets of transfer tubing 32, 34. When the pump 30 is actuated, it automatically dispenses a preprogrammed amount of sterile liquid 38 into the vial 10. Once the predetermined amount of sterile liquid 38 is transferred to the vial 10, the pump 30 automatically ceases operation. At this point, the technician removes the needle 28 from the vial septum 26 and inserts it into another vial septum of a vial (not shown) having dry, powdered medicament therein and manually actuates the pump 30. The vial 10 which has been filled with the predetermined amount of sterile liquid 38 is then shaken to thoroughly mix the powdered medicament 20 and the sterile liquid 38. This process is carried out for each of the required vials until they all have been reconstituted.
As can be seen from the foregoing description, the method of reconstituting the powdered medicament 20 is manually intensive. There is a need in the pharmaceutical compounding industry to reduce the number of steps in reconstituting the powdered medicament 20 to save time and effort in this process.
Once the powdered medicament 20 in the vials 10 has been reconstituted, it is then necessary to transfer the reconstituted powdered medicament to an IV bag or vacuum bottle for dispensing the reconstituted medicament to a patient, either through a syringe or infusion vial.
FIG. 2 shows the conventional, manually intensive, process of transferring reconstituted powdered medicament 42 from each of the vials 10 to an empty sterile container 44, such as an IV bag or vacuum bottle. First the pharmacy compounding technician must place a selected number of vials 10, the first and second sets of transfer tubing 32, 34, the pump 30 and an empty container 44 under the laminar flow hood (not shown) for the transfer process. The first set of transfer tubing 32 is then connected between the pump 30 and the empty container 44 by using the spike end 32a of the first set of transfer tubing 32 to access the empty container 44. The second set of transfer tubing 34 is connected to the pump 30 and at its distal end includes a Luer lock connector 40 to which the technician attaches a transfer needle 28.
The technician then transfers the reconstituted powdered medicament 42 within each vial 10 to the empty container 44. This process is accomplished by having the technician hold an inverted vial 10 in one hand while the other hand pierces the vial septum 26 with the transfer needle 28. The technician then manually actuates the pump 30 to extract the reconstituted powdered medicament 42 from the vial 10 and the reconstituted powdered medicament 42 flows through the first and second sets of transfer tubing 32, 34 and the pump 30, as represented by the arrows 42. As the reconstituted powdered medicament 42 is being transferred from the vial 10, the technician must be careful to withdraw all of the reconstituted powder medicament 42 and, therefore, must locate the tip of the transfer needle 28 just beyond the inner surface 26a of the vial septum 26, as shown in FIG. 2. Once the entirety of the reconstituted powder medicament 42 is withdrawn from the vial 10, the pump 30 either turns off automatically, or the technician must turn the pump 30 off manually. This process is repeated for all required vials until all of the reconstituted powdered medicament 42 has been transferred to one or more empty containers 44. The reconstituted powdered medicament 42 is then transferred from the container 44 directly to a patient or is then transferred to sterile delivery devices, such as syringes.
The foregoing process of transferring the reconstituted powdered medicament 42 to the empty container 44 is also highly labor intensive and takes a significant amount of time for the technician to complete. There is a need in the pharmacy compounding setting to reduce the amount of work necessary to transfer the reconstituted powdered medicament 42 to the empty container 44.
The present invention resulted from the inventors' observations of the foregoing problems and their successful efforts to solve them. With respect to reconstituting the powdered medicaments 20 in the vial 10, the present invention senses when the needle 28 has pierced the vial septum 26 and automatically turns the pump 30 on to transfer the predetermined quantity of sterile liquid 38 to the vial 10. With respect to transferring the reconstituted powdered medicament 42 from the vial 10 to the empty container 44, the present invention provides a vial support station which supports the vial 10 in an inverted position and senses when the vial 10 is located on the support station to automatically actuate the pump 30 and withdraw all of the reconstituted powdered medicament 42 from the vial 10 and transfer it to the empty container 44. Consequently, use of the present invention reduces the steps necessary to reconstitute powdered medicaments which are supplied in vials.